TECENTRIQ SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ATEZOLIZUMAB

זמין מ:

HOFFMANN-LA ROCHE LIMITED

קוד ATC:

L01FF05

INN (שם בינלאומי):

ATEZOLIZUMAB

כמות:

840MG

טופס פרצבטיות:

SOLUTION

הרכב:

ATEZOLIZUMAB 840MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

ANTINEOPLASTIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0158930001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2019-09-19

מאפייני מוצר

_Pr_
_Tecentriq_
_®_
_ (atezolizumab for injection) _
_Page 1 of 110_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TECENTRIQ®
atezolizumab for injection
Concentrate for solution for infusion, 60 mg/mL
1200 mg/20 mL and 840 mg/14 mL single use vials
For intravenous infusion
Professed Standard
ATC Code: L01FF05
Antineoplastic agent, monoclonal antibody
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario, Canada
L5N 5M8
www.rochecanada.com
Date of Initial Authorization:
Apr 12, 2017
Date of Revision:
Mar 13, 2024
Submission Control Number: 273807
TECENTRIQ® is a registered trademark of F. Hoffmann-La Roche AG, used
under license
©
Copyright 2023, Hoffmann-La Roche Limited
_ _
_Pr_
_Tecentriq_
_®_
_ (atezolizumab for injection) _
_Page 2 of 110_
RECENT MAJOR LABEL CHANGES
1 Indications
12/2022
4 Dosage and Administration
03/2024
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
03/2024
4 Dosage and Administration, 4.3 Reconstitution
03/2024
7 Warnings and Precautions
03/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.........................................................................................................
2
TABLE OF CONTENTS
...........................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................................................
4
1
INDICATIONS
..........................................................................................................................
4
1.1
Pediatrics
.........................................................................................................................5
1.2
Geriatrics
.........................................................................................................................5
2
CONTRAINDICATIONS
...................................................